Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dicycloverine hydrochloride
Phoenix Healthcare Distribution Ltd
A03AA07
Dicycloverine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01020000
731884 1065013426 PACKAGE LEAFLET: INFORMATION FOR THE USER DICYCLOVERINE HYDROCHLORIDE 10MG TABLETS TAKING THIS MEDICINE • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours please tell your doctor or pharmacist 1. What Dicycloverine hydrochloride Tablets are and what they are used for 2. Before you take Dicycloverine hydrochloride Tablets 3. How to take Dicycloverine hydrochloride Tablets 5. How to store Dicycloverine hydrochloride Tablets 6. Further information 1. WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS ARE Dicycloverine hydrochloride Tablets contain a medicine called dicycloverine hydrochloride. This belongs to a group of medicines called antispasmodics. WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS ARE USED FOR • Cramps • Pain in the stomach or intestine (gut) • Stomach or intestine (gut) problems - such as irritable bowel. HOW DICYCLOVERINE HYDROCHLORIDE TABLETS WORK Dicycloverine hydrochloride Tablets work by relaxing the muscles in your stomach and gut (intestine). It stops sudden muscle contractions (spasms). In doing this, it relieves cramps, pain, bloating, wind and discomfort. 2. BEFORE YOU TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS DO NOT TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS IF: × Y ou are allergic (hypersensitive) to dicycloverine hydrochloride or any of the other ingredients in Dicycloverine hydrochloride Tablets (see Section 6: Further information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dicycloverine hydrochloride Tablets. TAKE SPECIAL CARE WITH DICYCLOVERINE HYDROCHLORIDE TABLETS. CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING YOUR MEDICINE IF: You Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dicycloverine Hydrochloride 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of Dicycloverine hydrochloride. Excipient(s) with known effect: Each tablet contains 67.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off white, circular, flat beveled edge, uncoated tablet debossed with “S10” on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: 10-20 mg three times daily before or after meals. Children (2-12 years): 10 mg three times daily. Method of administration Oral 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Products containing dicycloverine hydrochloride should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition. Dicycloverine hydrochloride 10 mg Tablets contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy: Epidemiological studies in pregnant women with products containing dicycloverine hydrochloride (at doses up to 40 mg/day) have not shown that dicycloverine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy. Fertility: Reproduction studies have been performed in rats and rabbits at dos Lugege kogu dokumenti